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Medical Device Class 4 5 6 Steam Chemical Indicator Strips / Labels.
US$1.60-3.00
2,000 box
Sample price:US$5.00/box.Request sample

Product profile

Customization

Available

Usage

Dental Preventive Health Care Materials

Usage Times

Disposable

Model NO.

BF-BI4

Material

Paper

Applicable Departments

Dental Department

Nature

Specialized Instrument Equipment

Certification

CE

Sterile

Eo or Steam

Colors

Blue, Green, White etc.

Size

16X200mm

Transport Package

250PCS/Box

Specification

Class 4

Trademark

BINFEI

Origin

China

HS Code

3005109000

Production Capacity

25000boxes/Day

Key features

Class 4 Medical Grade: Level 4 medical steam indicator card complying with ISO11140 standards for precise sterilization monitoring.
Clear Color Change: Indicator changes from yellow to black (or pink to dark) to intuitively confirm sterilization success.
Dual Strip Design: Dual strips can be divided into two pieces for flexible use in various sterilization packages.
OEM Customization: Supports customized colors (Blue, Green, White, etc.) and sizes (e.g., 16x200mm) for OEM orders.
High Stability: Uses imported medical cardboard and chemicals; post-sterilization color is resistant to fading.
Wide Application: Suitable for pressure steam, pre-vacuum, and EO sterilization in hospitals, labs, and food industries.
Certified Quality: Products hold CE and ISO13485 certifications ensuring compliance with international medical standards.
Safe Material: Made from non-toxic, environmentally friendly water-based ink and leaf-free medical cardboard.

Company profile

Business Type: Manufacturer/FactoryExport Year: 2018-05-01Nearest Port: Qingdao, ShanghaiAverage Response Time: ≤3.64hTerms of Payment: LC, T/T, D/P, etc.International Commercial Terms(Incoterms): FOB, EXW, CFR, CIF, FAS, DDP, DAP, FCA

AI-Powered supplier vetting

SummaryZhucheng Binfei Medi-Tek Co., Ltd. is identified as a manufacturer/factory in Shandong, China, offering disinfection products, PPE, medical consumables, and dental products. It reports more than 10 production lines, 6–10 quality-control staff, ISO 13485 certification, OEM services, and exports to multiple global regions. Reported standard lead times are within 15 working days during off-peak periods and one month during peak periods. The supplier states that it has self-operated import/export rights and began exporting in 2018. Evidence supports production scale, export experience, and customization services, while after-sales capability, financial credibility, innovation strength, and specific customer cases remain insufficiently documented.
Supplier typeThe supplier is explicitly identified as a Manufacturer/Factory and Limited Company located in Shandong, China. Its listed products and business activities are concentrated in medical, PPE, disinfection, and dental consumables, indicating direct manufacturing involvement rather than a purely trading profile.
CertificationsThe supplier reports holding ISO 13485 certification, a quality-management standard relevant to medical-device production. No certificate number, issuing body, validity period, or scope is provided, so the assessment is based solely on the stated certification.
Production capacityThe supplier reports a family-owned factory alliance, strong production and delivery capability, more than 10 production lines, 6–10 quality-control staff, and lead times of within 15 working days off-season and one month during peak season. These statements support meaningful manufacturing capacity, although the reported staff experience of 4–10 years and absence of product-specific capacity data limit a fuller assessment.
Customization capabilityOEM services are explicitly offered, and the supplier states that it supports customers in different markets and aims to meet potential customer needs. This supports customization capability, although no details are given on tooling, artwork approval, minimum order quantities, sampling, or customization lead times.

Product Q&A

Q:What is the shelf life of the indicator strips?
A:
The product is valid for 18 months from the date of production.
Q:Can I customize the color and size of the strips?
A:
Yes, OEM is available. We can customize colors such as Blue, Green, and White, and sizes like 16x200mm.
Q:What standards do these indicators comply with?
A:
They comply with ISO11140 standards and are classified as Class 4 Medical Steam Indicator Cards.
Q:What is the packaging quantity per box and carton?
A:
There are 250 pouches per box and 100 boxes per carton.
Q:What certifications does the product have?
A:
The product holds CE and ISO13485 certifications.

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*To:Zhucheng Binfei Medi-Tek Co., Ltd.Zhucheng Binfei Medi-Tek Co., Ltd.
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